22-gauge Fine-Needle Aspiration System Versus 22-gauge ProCore Needle for the Evaluation of Pancreatic Mass Lesions at Endoscopic Ultrasound
This study has been completed.
Sponsor:
Shyam Varadarajulu
Information provided by (Responsible Party):
Shyam Varadarajulu, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01394159
First received: July 12, 2011
Last updated: December 26, 2011
Last verified: December 2011
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Purpose
The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.
| Condition | Intervention |
|---|---|
|
Pancreatic Neoplasm |
Procedure: Procore Biopsy Procedure: FNA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
Resource links provided by NLM:
Further study details as provided by University of Alabama at Birmingham:
Primary Outcome Measures:
- Compare the median number of passes required to establish a diagnosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | July 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ProCore Biopsy
Acquire biopsy with procore needle
|
Procedure: Procore Biopsy
Acquire tissue with procore biopsy needle
Other Name: Acquire tissue with ProCore needle
|
| Active Comparator: FNA |
Procedure: FNA
Acquire tissue with FNA needle
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-All patients with solid pancreatic mass lesions
Exclusion Criteria:
- Coaguloapthy,
- minors,
- prgenant patients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394159
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
Sponsors and Collaborators
Shyam Varadarajulu
Investigators
| Principal Investigator: | Shyam Varadarajulu, MD | University of Alabama at Birmingham |
More Information
No publications provided by University of Alabama at Birmingham
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shyam Varadarajulu, Principal Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01394159 History of Changes |
| Other Study ID Numbers: | F110506010 |
| Study First Received: | July 12, 2011 |
| Last Updated: | December 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
passes required to establish diagnosis |
Additional relevant MeSH terms:
|
Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013